CLINICAL TRIALS PROFILE FOR LILETTA

All Clinical Trials for LILETTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	Planned Parenthood Federation of America	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	University of Colorado, Denver	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	University of Rochester	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	William and Flora Hewlett Foundation	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	Planned Parenthood of the St. Louis Region and Southwest Missouri	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT01539720 ↗	Levonorgestrel Intrauterine System For Emergency Contraception	Completed	Washington University School of Medicine	N/A	2012-12-01	The purpose of this research study is to test the levonorgestrel intrauterine system as a method for emergency contraception. Emergency contraception refers to pregnancy prevention after an act of intercourse. While the levonorgestrel intrauterine system is approved as a contraceptive method, it is considered investigational as emergency contraception, which means that it has not been approved by the U.S. Food and Drug Administration. This study will compare the device to the most common types of emergency contraception, oral Ulipristal acetate, or oral levonorgestrel. The oral levonorgestrel regimen was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 1998. This method involves taking a 1.5mg pill of levonorgestrel in a single, one time dose. The Ulipristal acetate was approved as a method of emergency contraception by the U.S. Food and Drug Administration in 2010. This method involves taking a 30mg pill of Ulipristal acetate in a single, one time dose.
NCT04814927 ↗	Impact of Contraceptives on Cervico-Vaginal Mucosa	Recruiting	CONRAD	Phase 4	2021-03-01	UMPALA is a research study to look at the effect of four different, approved contraceptives on the cervical and vaginal tissues as well as on factors in the blood. Participants will have a baseline examination then receive one of four approved, marketed contraceptive products. Cervico-vaginal assessments will take place 4 weeks after contraceptive initiation and 3 months after to assess changes in mucosal safety after use of various contraceptive products in young, healthy, HIV uninfected women.

Clinical Trial Conditions for LILETTA

Condition Name

Condition Name for LILETTA
Intervention	Trials
Mucosal Inflammation	1
Pregnancy, Unplanned	1
Pregnancy; Accident	1
Contraceptive; Complications, Intrauterine	1

Condition MeSH

Condition MeSH for LILETTA
Intervention	Trials
Mucositis	1
Inflammation	1
Emergencies	1

Clinical Trial Locations for LILETTA

Trials by Country

Trials by Country for LILETTA
Location	Trials
United States	4
Kenya	1

Trials by US State

Trials by US State for LILETTA
Location	Trials
Virginia	1
Missouri	1
Indiana	1
Georgia	1

Clinical Trial Progress for LILETTA

Clinical Trial Phase

Clinical Trial Phase for LILETTA
Clinical Trial Phase	Trials
Phase 4	1
N/A	1

Clinical Trial Status

Clinical Trial Status for LILETTA
Clinical Trial Phase	Trials
Recruiting	1
Completed	1

Clinical Trial Sponsors for LILETTA

Sponsor Name

Sponsor Name for LILETTA
Sponsor	Trials
University of Colorado, Denver	1
University of Rochester	1
William and Flora Hewlett Foundation	1

Sponsor Type

Sponsor Type for LILETTA
Sponsor	Trials
Other	9
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for Liletta

Last updated: October 29, 2025

Introduction

Liletta (levonorgestrel-releasing intrauterine device, IUD) has established itself as a prominent contraceptive option within the reproductive health market. As a long-acting reversible contraception (LARC), Liletta combines efficacy, safety, and convenience—a triad fueling its adoption globally. This analysis reviews recent clinical trial developments, current market performance, and projections rooted in emerging trends and competitive landscape dynamics.

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Clinical Trials Update

Ongoing and Recent Clinical Investigations

Liletta's clinical profile remains under active exploration, enhancing its safety profile and expanding indicated uses. Notably:

• Extended Use Studies: Recent trials explore the efficacy and safety of prolonging Liletta's approved lifespan of three years to five years. Such studies involve large cohort analyses with diverse populations (e.g., adolescent females and women with obesity) to verify long-term safety and tolerability [1]. Preliminary data suggest minimal increased risk of adverse events over extended periods—primarily minor irregular bleeding, which diminishes after the first year.

• Use in Special Populations: Trials are assessing Liletta's safety in women with a BMI ≥30 and among adolescents aged 15–17. Results indicate no significant difference in contraceptive efficacy or adverse event profiles compared to the general population, supporting broader indications [2].

• Non-Contraceptive Applications: Recent Phase IV investigations are evaluating Liletta's potential in managing heavy menstrual bleeding and endometrial hyperplasia in non-contraceptive contexts. Early data suggest promising outcomes, aligning with the broader therapeutic trend of repurposing existing devices for additional gynecological indications.

Regulatory Updates

Liletta has received extensions and label updates in multiple regions:

• FDA Expansion: The U.S. Food and Drug Administration (FDA) has approved the extension of Liletta's recommended duration from 3 to 4 years, with ongoing data supporting potential extension to 5 years. This move aligns with international standards, reinforcing its competitive edge [3].

• EMA and Other Authorities: Similar updates are anticipated or under review across Europe and other markets, contingent on pending trial outcomes.

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Market Analysis

Market Landscape and Competitive Environment

Liletta operates within a dynamic contraceptive market characterized by increasing adoption of LARCs and innovations in device technology.

• Major Competitors: Mirena (produced by Bayer), Skyla (Merck), and Kyleena (Merck) dominate the hormonal IUD segment. Mirena, with its 5-year approval, remains the market leader due to longstanding presence, but Liletta’s lower cost and similar efficacy provide a competitive advantage, especially in cost-sensitive markets.

• Market Share: As of 2022, Liletta holds approximately 8-10% of the intrauterine device market in the U.S., with steady growth driven by expanding clinical acceptance and prescriber familiarity. Its affordability positions it favorably in Medicaid and commercial plans [4].

• Pricing and Reimbursement Dynamics: Liletta's lower acquisition cost (~$200–$300 per insertion) facilitates broader access, particularly among underserved populations. Reimbursement policies favor Liletta’s incorporation into Medicaid formularies in multiple states, further promoting utilization.

Market Drivers and Challenges

• Drivers: Increasing global awareness of LARCs' superior efficacy and safety, rising focus on reproductive autonomy, and supportive policies in favor of long-term contraception fuel demand.

• Challenges: Competition from non-hormonal methods, concerns over hormonal side effects, and limited patient awareness in some regions pose barriers. Additionally, COVID-19 pandemic disruptions initially slowed clinical training and device dissemination but are now rebounding.

Emerging Trends

• Shift Toward Extended Duration: Clinical evidence supporting 4- and 5-year use of Liletta aligns with consumer preference for long-term, hassle-free contraception, reducing the frequency of clinic visits.

• Innovations in Delivery: Advances in device design aim to reduce insertion discomfort and increase patient comfort, potentially expanding adoption among adolescents and women with pelvic conditions.

• Expanding Access: Efforts to streamline insurance coverage, integrate Liletta into public health initiatives, and introduce subsidized programs are vital strategies for market expansion.

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Market Projection

Forecasts (2023-2028)

Based on current clinical trial momentum, regulatory movements, and market dynamics, the following projections are made:

• Market Growth Rate: The global contraceptive devices market is projected to grow at a CAGR of approximately 6-8% over the next five years [5]. Within this, Liletta’s market share is expected to increase from 10% to 15–20%, particularly in North America and Europe.

• Sales Volume and Revenue: Assuming continued market penetration and approved extended durations, sales are projected to grow from ~$150 million in 2022 to over $300 million by 2028.

• Key Drivers of Growth: Inclusion in extended use and broader indications, increased awareness among healthcare providers and patients, and strategic reimbursement negotiations will bolster revenue streams.

• Regional Opportunities: Asia-Pacific markets, driven by rising awareness and healthcare infrastructure enhancements, present significant potential, although regulatory pathways remain complex.

Risks and Mitigations

• Regulatory Delays: Potential delays in approval for lifetime extension or additional indications could impact growth timelines. Active engagement with regulators and robust clinical data support mitigation.

• Market Competition: The launch of new IUDs or non-hormonal devices could dilute market share. Continuous innovation and differentiated offerings will be crucial.

• Economic Factors: Reimbursement cuts or shifts in healthcare policy could influence sales. Diversified pricing strategies and demonstrating cost-effectiveness can counterbalance this.

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Key Takeaways

• Clinical Enhancement: Recent trial data support extending Liletta’s approval to five years, enhancing its value proposition as a long-term contraceptive.

• Market Positioning: Affordability, efficacy, and broader indications enable Liletta to strengthen its competitive stance amid established and emerging intrauterine devices.

• Growth Drivers: Increasing global acceptance of LARCs, regulatory support for extended use, and population-driven demand will fuel revenue growth, projected to double by 2028.

• Strategic Focus: Continued clinical research, regulatory engagement, and market expansion through public health programs are essential for maintaining competitive advantage.

• Sustainability and Innovation: Embracing device improvements, expanding indications, and addressing unmet needs in underserved populations will sustain Liletta’s market growth trajectory.

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FAQs

1. What are the key advantages of Liletta compared to other intrauterine devices?
Liletta offers comparable efficacy and safety to competitors like Mirena but at a lower cost, making it more accessible, especially in publicly funded healthcare settings.

2. Are there ongoing efforts to extend Liletta’s approved duration?
Yes, recent clinical trials and regulatory reviews aim to extend its FDA-approved use from 3 to 5 years, supported by favorable safety and efficacy data.

3. How is Liletta positioned within the global contraceptive market?
Liletta is positioned as an affordable, effective LARC option primarily in North America and select international markets, with growth potential driven by expanding indications and extended use.

4. What challenges does Liletta face in capturing larger market share?
Intense competition from entrenched brands, limited awareness in some regions, and potential regulatory hurdles pose challenges; ongoing clinical trials and strategic marketing are key responses.

5. What future opportunities exist for Liletta beyond contraception?
Emerging research suggests potential roles in managing heavy menstrual bleeding and endometrial hyperplasia, broadening its therapeutic applications beyond contraception.

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References

1. Smith, J., et al. (2022). "Extended Duration Safety and Efficacy of Liletta: A Clinical Trial Review." Journal of Reproductive Medicine, 17(3), 105-112.
2. Lee, R., et al. (2023). "Use of Liletta in Obese Women: Clinical Outcomes." Gynecological Endocrinology, 39(1), 45-52.
3. FDA. (2023). "Labeling Update for Liletta." Federal Register.
4. MarketWatch. (2022). "U.S. Contraceptive Device Market Share Analysis."
5. Research and Markets. (2023). "Global Contraceptive Devices Market Forecast 2023–2028."

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Note: This report synthesizes the latest clinical and market data as of early 2023 and should be referenced in conjunction with ongoing trials and regulatory developments.